Phase II Trial of Polyphenon E in Former Smokers With Abnormal Sputa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Changes in oncogene/tumor suppression gene expression (part 1; completed March 22, 2006)
研究概览
简要总结
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. Green tea extract may keep cancer from forming.
PURPOSE: This randomized phase II trial is studying green tea extract in preventing cancer in former and current heavy smokers with abnormal sputum.
详细描述
OBJECTIVES:
- Evaluate the efficacy and safety of defined green tea catechin extract (polyphenon E) in former smokers with abnormal sputum score using stringent, newly developed response criteria of combined nuclear morphometry and malignancy-associated changes as the primary surrogate endpoint.
- Evaluate if polyphenon E can modulate other surrogate endpoint biomarkers of aberrant methylation, cell cycle regulation, apoptosis, oncogene/tumor suppressor gene expression, as well as phase I and II enzyme regulation.
- Establish a library of in-vivo confocal micro-endoscopy and optical coherent tomography images of the bronchial epithelium with corresponding histopathology, nuclear morphometry, and other biomarker information to assess the potential of confocal micro-endoscopy as a non-biopsy method to assess the effect of chemoprevention agents.
OUTLINE: This is an open label, part 1 study followed by a randomized, double-blind, part 2 study.
- Part 1 (completed March 22, 2006): Patients receive oral defined green tea catechin extract twice daily in months 1 and 2 and inhaled budesonide twice daily in month 2.
Patients undergo autofluorescence bronchoscopy with biopsies, oral and bronchial brushing, and bronchoalveolar lavage at the end of months 1 and 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive oral defined green tea catechin extract twice daily for 6 months.
干预措施: defined green tea catechin extract (Drug)
Arm II
Patients receive oral placebo twice daily for 6 months.
干预措施: placebo (Other)
结局指标
主要结局
Changes in oncogene/tumor suppression gene expression (part 1; completed March 22, 2006)
时间窗: 36 months
Phase I and II enzyme regulation by Affymetrix chip analysis in bronchial brush cells (part 1)
时间窗: 60 months
C-reactive protein level in plasma before treatment and 1 and 2 months after treatment (part 1)
时间窗: 60 months
Quantitative sputum score by image analysis before and 6 months after treatment (part 2)
时间窗: 36 months
次要结局
- Change in pathology grade of bronchial biopsies (part 2)(36 months)
- Morphometric index of bronchial biopsies and bronchoalveolar lavage cells (BAL) (part 2)(36 months)
- Methylation markers in sputa and BAL cells (part 2)(60 months)
- Ki-67 expression (part 2)(60 months)
- Cleaved caspase 3, p53, and VEGF assays in bronchial biopsies (part 2)(60 months)
- Oncogene and tumor suppression gene expression (part 2)(60 months)
- Phase I and II enzyme regulation by Affymetrix chip analysis of RNA from bronchial brush cells (part 2)(60 months)
- C-reactive protein levels in plasma before treatment, and 6 months after treatment (part 2)(36 months)
- Resolution or progression of non-calcified lung nodules on spiral CT (part 2)(60 months)